Method and Device for Connecting a Conduit to a Hollow Organ

ABSTRACT

This invention provides an improved method for connecting a conduit to a hollow organ/structure and a unique device consisting of an expandable metallic mesh and a bio-compatible graft material.

FIELD OF THE INVENTION

This invention relates to methods and device in general, and moreparticularly to surgical methods and device for connecting a conduit toa hollow organ/structure.

BACKGROUND

Heart failure amounts for the largest area of spending by the Medicareamounting to 33 billion dollars a year. Heart disease remains one of thecommonest diseases in the western world (1). One option for patientswith end stage heart disease is transplant, but the limited donoravailability makes this option extremely limited (approximately 2000patients per year). Ventricular assist devices (VAD) have proven to be areliable method of treating these patients by giving them survivalbenefit as well as good quality of life. These devices commonly attachbetween the left ventricle and transport blood to the ascending aorta tobypass the left ventricle. For supporting the right ventricle they areusually take blood from the right atrium and return it to the pulmonaryartery thus bypassing and taking over the function of the rightventricle.

Although several technological modifications have been undertaken toimprove on the reliability and improved functioning of these devices,specifically reducing the mechanical failure, the inflow cannula thatconnects the heart chambers to that of the VAD have remained unchangedfor the large part. All the current devices use a tubular cannula madeup of rigid material that protrudes within the lumen of the heartchamber.

This often leads to malposition, suction events due to collapse ofchamber wall, abnormal eddy currents that can lead to thrombus formationand intermittent and sometime fatal pump dysfunction. Some designcharacteristics of the current cannula incorporate fenestrations orbevels at the tip or cages to prevent total obstruction of the cannulaand optimize flow (2,3). Common problems with current cannulas have beenwell documented; intra-operative position of the cannula may bedisplaced following the closure of the patient necessitating design offlexible cannula with rigid tips (4-13).

Some design improvements have been reported to the cannula design butall of them require the chamber to be opened surgically and theninserting the cannulas, which is cumbersome and increases damage to thechamber (12-14). Additionally these are bulky devices unable to beflexible enough to allow minimally invasive approached to the placementof the cannula, which can be connected to the VAD device.

Several interventions within the heart structures and related bloodvessels need an access and exit to the cardiac chambers. For this thecardiac apex is an ideal route allowing for a very short and directroute. For example, insertion of a stent mounted aortic valve, transapical aortic or mitral valve replacement, atrial fibrillation ablation,insertion of a aortic stent graft or intervening on the coronaries canbe done easily via the apex of the left ventricle. There is limitedavenues for accessing and closing the heart apex at this stage, most ofthem involve inserting a titanium screw and cap, or surgical placementof sutures or polypropylene suture placement device.

Some prior art, in attempting to develop connector devices that implantin the heart wall, assumes a smooth heart wall of constant thickness andoperates by sandwiching tissue between opposing parallel plates. See,for example, FIG. 12B of U.S. patent application Ser. No. 11/770,288,filed Jun. 28, 2007 by William E. Cohn for AUTOMATED SURGICAL CONNECTOR,and FIGS. SA and SB of U.S. patent application Ser. No. 11/251,100,filed Oct. 14, 2005 by Thomas Vassiliades eta. for VASCULAR CONDUITDEVICE AND SYSTEM FOR IMPLANTING, which two patent applications arehereby incorporated herein by reference. In reality, however, theinterior of the left ventricle of the heart is generally not a smoothcontinuous surface, and the wall thickness of the left ventriclegenerally varies considerably within any given patient, and also frompatient to patient. As a result, the methods and apparatus disclosed inthe aforementioned U.S. patent applications Ser. Nos. 11/770,288 and11/251,100 can present issues when applied in actual patient anatomies.

Some references that discuss the requirements for successfulimplantation of an apico aortic conduit are listed below:

-   1. AHA annual statistics.-   2. Holman, W. L., et al., Left atrial or ventricular cannulation    beyond 30 days for a Thoratec ventricular assist device. ASAIO    J, 1995. 41(3): p. M517-22.-   3. Lohmann, D. P., et al., Left ventricular versus left atrial    cannulation for the Thoratec ventricular assist device. ASAIO    Trans, 1990. 36(3): p. M545-8.-   4. Badiwala, M. V., H. J. Ross, and V. Rao, An unusual complication    of support with a continuous-flow cardiac assist device. N Engl J    Med, 2007. 357(9): p. 936-7.-   5. Amin, D. V., et al., Induction of ventricular collapse by an    axial flow blood pump. ASAIO J, 1998. 44(5): p. M685-90.-   6. Reesink, K., et al., Suction due to left ventricular assist:    implications for device control and management. Artif Organs, 2007.    31(7): p. 542-9.-   7. Watanabe, K., et al., Development of a flexible inflow cannula    with titanium inflow tip for the NEDO biventricular assist device.    ASAIO J, 2004. 50(4): p. 381-6.-   8. Hetzer, R., Proceedings of the 4th Berlin Symposium on Mechanical    Circulatory Support. J Card Surg, 2006. 21: p. 512-520.-   9. Snyder, Preclinical Biocompatibility Assessment of Cardiovascular    Devices in Bioengineering in Bioengineering. 2006, University of    Pittsburgh.-   10. Miyake, Y., et al., Left ventricular mobile thrombus associated    with ventricular assist device: diagnosis by transesophageal    echocardiography. Circ J, 2004. 68(4): p. 383-4.-   11. Votapka, T. V., et al., Left ventricular cannula obstruction in    a patient with previous ventricular aneurysmectomy. Ann Thorac    Surg, 1994. 58(4): p. 1182-4.-   12. Griffith, B. P., et al., HeartMate II left ventricular assist    system: from concept to first clinical use. Ann Thorac Surg, 2001.    71(3 Suppl): p. S116-20; discussion S114-6.-   13. Vollkron, M., et al., Suction events during left ventricular    support and ventricular arrhythmias. J Heart Lung Transplant, 2007.    26(8): p. 819-25.-   14. Antaki, J. F., et al., An improved left ventricular cannula for    chronic dynamic blood pump support. Artif Organs, 1995. 19(7): p.    671-5.-   15. Curtis, A. S., et al., Novel ventricular apical cannula: in    vitro evaluation using transparent, compliant ventricular casts.    ASAIO J, 1998. 44(5): p. M691-5.-   16. ASAIO Bioengineering/Tissue Engineering Abstracts. ASAIO    Journal, 2007. 53(2): p. A1-69.

The present invention addresses the aforementioned difficultiesassociated with connecting an implantable connector to a holloworgan/structure.

SUMMARY

A main object of the present invention is to provide a self-expandingmuscular hollow organ connection device and a method of inserting suchdevice. Specifically, the invention provides an improved access methodand a cannula device that allows the improved access method. Theproposed device design consists of an expandable metallic mesh and abio-compatible graft material.

In one embodiment, the device consists of an expandable metallic mesh.The mesh can consist of a material selected from Co—Cr, Stainless Steel,and a shape memory material. In another embodiment, the shape memorymaterial is nitinol or a nitinol alloy.

In another embodiment, the device has a first portion, a second portion,and a middle portion. The first and second portions can be located atopposite ends of the middle portion. In another embodiment, the firstportion and second portion independently can contain one or more barbsat or near the edge of said portions for the purpose of self-anchoringthe device once inserted into the hollow organ.

In another embodiment, the middle portion contains a bio-compatiblegraft material attached on the inside of the middle portion of thedevice. The graft material can be selected from one of Dacron, ePTFE andPTFE, polyester, polytetrafluroethylene, and collagen.

In yet another embodiment, the bio-compatible graft material can beselected from one of a polyester, polytetrafluoroethylene and collagenwhich is attached to the outside of the metallic mesh and locatedbetween the mesh and the organ tissue.

In another embodiment, the device is made of uni-body construction, cutfrom a nitinol tube. The process for making the device further comprisespartially expanding a first portion and a second portion. Each portionis attached at opposite ends to a middle portion, and the first andsecond portions are thermally treated to form a flower shape.

In yet another embodiment, the device is made from a Co—Cr or stainlesssteel wire.

In one embodiment, the device is straightened, crimped and loaded into asmall profile delivery system and thereafter deployed at the intendedorgan. Once deployed, the device regenerates back to its originalexpanded state. Upon expansion, the graft material attached to theinside of the middle portion of the device becomes a conduit thatprovides smooth access into and out of the hollow organ. The expandeddevice is further capable of spontaneous closure. When closed, thedevice provides a leak proof access point.

In one embodiment, the invention proposes a method of delivery of atranscutaneous or transapical aortic or mitral valve, manipulation ofaortic or mitral valve or ablation of atrial fibrillation or insertionof a coronary stents or aortic stent grafts through the apex of the leftor right ventricle or through a the wall of any cardiac chambers. Theinvention will allow a secure closure after the manipulating catheter ordelivery system is removed.

In one embodiment, the invention provides a method of making aconnection to a muscular hollow organ, facilitating entry and exit tosaid organ. In a further embodiment, the muscular hollow organ is theheart.

In another embodiment the device is a ventricular apical access device.

In yet another embodiment the method is an improved method forventricular apical access to the heart. In a further embodiment, theventricular apical access is to the left ventricle.

In yet another embodiment the method is an improved method forconnecting the heart's vessels and chambers to the exterior by use of aDacron, PTFE, polyester, nylon, or polypropylene tube material.

In another embodiment the device is used as a single multi-access siteto a muscular hollow organ for surgical procedures. Some surgicalprocedures that may be improved by the use of the device of the presentinvention can be selected from the group consisting of ventricularapical access, percutaneous valve delivery, percutaneous gastrostomy,cystostomy, colostomy, ventriculoperotoneal shunt or any shuntprocedures between blood vessels, and connection between hollow organsand exterior or to another hollow organ.

In yet another embodiment the procedure that may be improved by the useof the device is a post-operative procedure such as for example, supportto the failing heart chambers.

The invention, as represented in one or more embodiments, has manyadvantages including but not limited to the following:

-   1. The device can be straightened and crimped to fit into a delivery    device and then self-expands once deployed, thus making the    procedure minimally invasive.-   2. The device provides an improved connection to a hollow organ    allowing spontaneous flow shut-off.-   3. After implantation of the device into the wall of a hollow organ,    a medical device can be easily delivered.-   4. The device can provide a single multi-access site due to the    super-elasticity of the nitinol frame, and-   5. After implantation, the self-expanding and self-closing device    can be secured to the heart without suturing.

Other details, objects, and advantages of the invention will becomeapparent from the following detailed description and the accompanyingdrawings and figures of certain embodiments thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of a self-expanding muscular hollow organconnection device in accordance with the present invention.

FIG. 2 is a side view of a self-expanding muscular hollow organconnection device in accordance with the present invention.

FIG. 3 is a cut tube prior to shape-setting.

FIG. 4 is a top view and a side view of a self-expanding muscular holloworgan connection device expanded for cannulation in accordance with thepresent invention.

FIG. 5 is a schematic view showing the deployment of the device in FIGS.1, 2 and 4 into the left ventricle of a heart. The device is in thenormally closed configuration.

FIG. 6 is a schematic view showing the opening of the device in FIGS. 1,2 and 4 once inserted into the left ventricle of the heart, for thepurpose of cannula insertion.

FIG. 7 shows the top and side viewss of a self-expanding muscular holloworgan connection device in the “normally closed” position and the“pushed open” position, and a schematic of the device in both positionsonce inserted into the hollow organ in accordance with the presentinvention.

FIG. 8 is a schematic showing the deployment of a muscular hollow organconnection device, the self-expanding mechanism of the nitinol frame tothe normally open configuration and the graft material creating aconduit allowing for multiple surgical procedures in accordance with thepresent invention. Also shown is the placement of a clip on the graftmaterial lining the inside of the frame that seals the opening of theaccess point.

DETAILED DESCRIPTION

Definitions:

For the purposes of the present disclosure, the following terms shallhave the associated meanings. Reference in any given embodiment to aterm defined below is to be understood as incorporating the broadestdefinition of such term.

The term “cannula” shall mean a tube which can be permeable,impermeable, partially permeable, partially impermeable, or selectivelypermeable to fluid.

The term “stent” shall mean a structure that can support an anatomicalstructure, such as, but not limited to, a blood vessel, intestine orother structure, by exerting a force counter to a collapsing orshrinking force exerted by the anatomical structure.

The term “conduit” shall mean a fluid impermeable tube capable ofconducting a fluid from a first location to a second location.

The terms “ePTFE” and “PTFE” shall mean expanded polytetrafluorethyleneand polytetrafluorethylene respectively.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like parts aredesignated by like numerals throughout. It will be readily understoodthat the components of the present invention, as generally described andillustrated in the figures herein, could be arranged and designed in awide variety of different configurations. Thus, the following moredetailed description of the embodiments of the apparatus, system, andmethod of the present invention, as represented in FIGS. 1 through 8, isnot intended to limit the scope of the invention, as claimed, but ismerely representative of presently preferred embodiments of theinvention.

As illustrated in FIGS. 1 and 2, a device (10) for use in connecting toa hollow organ, is comprised of an expandable metallic mesh. The devicehas a first top portion (11), a second bottom portion (12), and a middleportion (14). The top (11) and bottom (12) portions are located atopposite ends of the middle portion (14). The device configuration inFIGS. 1 and 2 is cut from a nitinol tube (FIG. 3) and the top and bottomportions are partially expanded and thermally treated to form a flowershape. The metallic mesh material is a super elastic nitinol materialwhich is super-elastic at body temperature.

Once inserted into the hollow organ, the top and bottom portions are incontact with an inner and outer wall respectively. The device (10)further independently comprises one or more barbs (13) at or near theedge of each of the first top portions and second bottom portions toenable self-anchoring of the device.

One unique aspect of the device (10) according to the present inventionis its ability to self-expand (FIG. 4) once deployed into the holloworgan, for cannulation. In a preferred embodiment, the device (10) isdeployed to the left ventricle of the heart by means of a small profiledelivery catheter. Once inserted the super-elastic nitinol frame revertsto its normal open configuration (FIG. 4). The frame anchors itself tothe inner and outer walls of the ventricle using barbs (13). The device(10) further comprises a bio-compatible graft material (16) located onthe inside of the middle portion (14) of the frame, such as, forexample, Dacron, ePTFE, PTFE and polyester. When opened for cannulationas shown in FIG. 4, the graft material becomes a conduit that providessmooth access to the ventricle. When deployed closed, the frame and thegraft material maintain a leak-proof environment.

As illustrated in FIG. 5 the deployment sequence of the device (10) intothe left ventricle of a heart, shows the delivery catheter having thedevice (payload) therein entering the left ventricle of the heart. Oncecontacting the inner wall of the ventricle, the first or top portion(11) of the device self-anchors into the inner wall by means of thebarbs. Additionally, the bottom or second portion (12) of the device(10) engages with the outer wall and self-anchors thereto by means ofthe barbs.

In a particular embodiment, the barbs grab the heart tissues forstability. By capturing the muscle tissues inside and outside theventricle during deployment, the device (10) moves along with thesurrounding tissue and provides securement.

In a specific embodiment, the schematic view in FIG. 6 illustrates theopening of the device (10) of FIGS. 1, 2 and 4 once inserted into theleft ventricle of the heart, for the purpose of cannula insertion.

This improved method of using the device (10) as depicted in FIG. 6,allows the site to be accessed multiple times for post-op procedures orother surgical procedures. Some procedures capable of being performedincorporating the use of device (10) of the present invention can be butare not limited to ventricular apical access, percutaneous valvedelivery, percutaneous gastrostomy, cystostomy, colostomy,ventriculoperotoneal shunt or any shunt procedures between bloodvessels, and connection between hollow organs and exterior, or toanother hollow organ and the like.

As depicted in FIG. 7 the top and side views of a self-expanding holloworgan connection device (10) is shown in the “normally closed” positionand the “pushed open” position. In addition, a schematic illustrates thedevice in both positions once inserted into a hollow organ in accordancewith the methods of the present invention.

The present invention describes the method of deployment, schematicallyshown in FIG. 8, of a hollow organ connection device, the self-expandingmechanism of the nitinol frame to the normally open configuration andthe graft material creating a conduit allowing for multiple surgicalprocedures in accordance with the present invention. In a furtherembodiment a clip is placed on the outwardly extending end of the graftmaterial lining the inside of the frame, extending from the outer wallof the organ, which seals the opening of the access point.

This invention describes a new improved method of providing aself-expanding hollow organ connection device to a hollow organ. In onepreferred embodiment, the organ is a muscular hollow organ, such as forexample, the left ventricle of a human heart. This invention could beuseful in other organs in a human or animal such as the right ventricle,the left or right atrium, the stomach, the bladder, blood vessels orother fluid filled organs.

Generally described, the invention consists of a self-expanding holloworgan connection device (10) consisting of a metallic mesh material anda bio-compatible graft material. The metallic mesh material forms aframe consisting of a top portion (11) a bottom portion (12) and amiddle portion (14). The metallic mesh material useful in the methods ofthe present invention includes, but is not limited to, substancesbiologically inert and capable of forming a structure or with somedegree of elastic properties. A wide range of materials including, butnot limited to, metals, such as, but not limited to stainless steel andsilver, nitinol, co—cr alloy, plastics, monofilament or multifilamentpolymer, shape memory polymers, or biological tissues or the like and/ormixtures, combinations, alloys or composites thereof, may be suitable.

In one embodiment the shape memory material is nitinol or a nitinolalloy material. Nitinol is a nickel-titanium alloy and probably the bestknown representative of the shape-memory alloys. Nitinol has a cubiccrystal structure which comprises approximately 55 wt. % nickel and theremainder titanium. The alloy is usable up to 650° C., is corrosionresistant, and is very strong. The alloy is pseudo-elasticallydeformable up to approximately 8%. Shape-memory alloys, are well knownin the art, in particular, nitinol, are used in medical technology inthe form of, inter alia, self-expanding stents. A stent is a medicalimplant which is introduced into specific organs to support their wallsall the way around. The nitinol stent is a small tubular supportstructure comprising nitinol, which may assume a compressed state havinga small diameter and an expanded state having an enlarged diameterpredefinable for the intended purpose.

The bio-compatible graft material useful in the present invention can beattached to either the inside, outside or both sides of the metallicmesh frame. For purposes of the present invention, the graft materialwhen attached to the inside of the metallic mesh frame serves as aconduit allowing smooth access into and out of the hollow organ.Suitable bio-compatible graft materials for attachment on the inside ofthe mesh, include but are not limited to, Dacron, ePTFE, PTFE, andpolyester. When attached to the outside of the frame, the graft materialis placed between the frame and the organ tissue allowing the tissue togrow or fuse with the frame. Suitable graft materials for placementbetween the frame and the tissue include but are not limited to, Dacron,polyester, and collagen.

In one aspect of the invention, the device (10) can be used as a singlemulti-access site to a hollow organ for surgical procedures. Suchprocedures can be selected from but not limited to ventricular apicalaccess, percutaneous valve delivery, aortic valve repair, mitral valverepair, PFO (Patent Foramen Ovale), percutaneous gastrostomy,cystostomy, colostomy, ventriculoperotoneal shunt or any shuntprocedures between blood vessels, and connection between hollow organsand exterior or to another hollow organ.

Furthermore, the device (10) can be used as a single multi-access siteto a hollow organ for post-operative procedures such as for example,support to the failing heart chambers.

In accordance with the above description, the present inventiondescribes a new improved method of providing a self-expanding holloworgan connection device to a hollow organ. In one embodiment, the device(10) is loaded into a catheter and delivered to the hollow organ withminimal invasion. Upon first deployment of the device (10) at the organsite, the barbs on the first or top portion (11) of the device engagethe inner wall. Upon complete deployment, the barbs on the second orbottom portion (12) engage the outer wall of the organ. For the purposeof the present invention, the barbs capture the tissues inside andoutside during deployment, thereby allowing the device to move alongwith the surrounding tissue and provide securement of the connectiondevice (10). The construction and composition of the device (10) allowsit to be straightened, crimped and loaded in a small profile deliverysystem such as for example, a catheter. Upon deployment, the devicecomposed of, for example, nitinol or a nitinol alloy material, resumesits original shape due to the super-elastic nature of the shape memorymaterial, thereby forming the improved connection to the hollow organ.

As described earlier, the improved connection to a hollow organ providedaccording to the methods of the present invention, can serve as amulti-access point for surgical and post-surgical procedures on holloworgans thereby limiting the need for additional access points andreducing the stress and trauma often associated with such invasiveprocedures.

While the above description focuses primarily on attachment of aconnection device to a hollow organ, such as a heart, it should beunderstood that the same device and procedures will allow attachment ofthe devices to other hollow organs, for example but not limited togastrointestinal and urinary organs (i.e. for electrical stimulation andor monitoring of the GI tract), access to the bladder for enhancement offunction or treatment of disease such as bladder cancer, implantation ofapparatus such as stomach bypass tubes for treatment of morbid obesityor for limiting passage through the pylorus valve, access for implantingaugmentation or enhancement devices for closure of body lumens such asmagnetic or mechanical sphincters, endoscopic delivery means fordiagnosing/treating gastric disorders, delivery of a resident sensingdevice, therapeutic delivery device, access means for removing tumorsfrom hollow organs, access means for delivering and removing tumortreatment devices (i.e. radiation devices), access means for attachinggraft to blood vessels, means of simultaneous cut-and-attach graft, andthe like.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention.

Accordingly, it is to be understood that the drawings and descriptionsherein are proffered by way of example to facilitate comprehension ofthe invention and should not be construed to limit the scope thereof.

What is claimed is:
 1. A self-expanding hollow organ connection device(10) consisting of a metallic mesh material and a bio-compatible graftmaterial wherein said device has a first portion (11), a second portion(12), and a middle portion (14), wherein said first (11) and second (12)portions are located at opposite ends of said middle portion (14), andwherein a first portion is in contact with a first inner wall of saidorgan and a second portion is in contact with a second outer wall ofsaid organ.
 2. The device of claim 1 wherein the first portion andsecond portion independently contain one or more barbs (13) at or nearthe edge of said portions.
 3. The device of claim 1 wherein the deviceis self-anchoring.
 4. The device of claim 1 wherein the metallic meshmaterial is a bio-compatible metal material.
 5. The device of claim 4wherein the metallic mesh material is selected from the group consistingof Co—Cr, stainless steel and silver, nitinol, plastics, monofilament ormultifilament polymer, shape memory polymers, and biological tissues andmixtures, combinations, alloys and composites thereof.
 6. The device ofclaim 1 wherein the metallic mesh material consists essentially of ashape memory material.
 7. The device of claim 6 wherein the shape memorymaterial is selected from the group consisting of a super-elasticnitinol and a super-elastic nitinol alloy.
 8. The device of claim 1wherein said bio-compatible graft material (16) is attached to theinside of the middle portion (14) of the metallic mesh.
 9. The device ofclaim 1 further comprising a second bio-compatible graft material (15)attached to the outside of the metallic mesh.
 10. The device of claim 8wherein the bio-compatible graft material (16) is selected from thegroup consisting of Dacron, ePTFE, polytetrafluorethylene, andpolyester.
 11. The device of claim 9 wherein the second bio-compatiblegraft material (15) attached to the outside of the metallic mesh islocated between the mesh and the organ tissue and is selected from thegroup consisting of Dacron, polyester and collagen.
 12. The device ofclaim 1 wherein said device is a uni-body construction.
 13. The deviceof claim 1 wherein said device is leak-proof when not expanded.
 14. Thedevice of claim 1 wherein said device is capable of being straightened,crimped and loaded into a small profile delivery system.
 15. The deviceof claim 1 wherein the device is a ventricular apical access device. 16.A method of making a connection to a hollow organ, facilitating entryand exit to said organ comprising: a. providing the device (10) of claim1; b. straightening and crimping said device (10), and loading it into asmall profile delivery system, and c. deploying said device (10) in thehollow organ.
 17. The method of claim 16 further comprising, afterdeployment of the device (10), said device containing the graft materialon the inside of the middle portion (14) self-expands and remains in theopen position, thereby providing a conduit for smooth access.
 18. Themethod of claim 17, further comprising, the middle portion (14) ofdevice (10) of claim 1, spontaneously returning to a non-expanded state,thereby making the connection leak-proof.
 19. The method of claim 16,wherein the hollow organ is the heart.
 20. The method of claim 16wherein, the method is an improved method for ventricular apical accessto a hollow organ, wherein the organ is the heart and wherein theventricular apical access is to the left ventricle.
 21. The use of thedevice (10) of claim 1 as a single multi-access site to a hollow organfor surgical procedure.
 22. The use according to claim 21 wherein, thesurgical procedure is selected from the group consisting of ventricularapical access, percutaneous valve delivery, aortic valve repair, mitralvalve repair, PFO (Patent Foramen Ovale), percutaneous gastrostomy,cystostomy, colostomy, ventriculoperotoneal shunt or any shuntprocedures between blood vessels, and connection between hollow organsand exterior or to another hollow organ.
 23. A method of making thedevice (10) of claim 1 wherein the device is cut from a nitinol tube,said method further comprising, a. partially expanding a first portion(11) and a second portion (12) attached at opposite ends to a middleportion (14), and b. thermally treating said first and second portionsto form a flower shape.
 24. A method of making the device (10) of claim1 where in the device is made from a bio-compatible metallic wireselected from the group consisting of Nitinol, Co—Cr, and StainlessSteel.